Bio/Pharma Product Testing Services >> Method Development >> Impurities Testing for Pharmaceutical Products and APIs

Impurities Testing for Pharmaceutical Products and APIs

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From residual solvents and process-related impurities to extractables/leachables and degradant-related impurities, Eurofins Lancaster Laboratories offers a broad range of services in support of impurities testing. We are able to identify and quantify very low levels of impurities in the most difficult of sample matrices.

Why Choose Eurofins Lancaster Laboratories?

  • You can easily identify extractable compounds detected by LC/MS analysis, using our non-volatile compound database consisting of more than 120 compounds.
  • If you have a short-term or infrequent need for testing, our self-validating method approach for residual solvents testing is a faster and more cost-effective option.
  • For unknown impurity identification, we offer the most extensive range of mass spectrometric approaches, including accurate mass.
  • Our 30-year history of cGMP regulatory compliance ensures that you get the highest quality data.
  • With extensive expertise in developing, validating and providing testing support for impurities, we can provide you with the best strategy for monitoring impurities and accelerating your drug development programs.

Testing Available

  • Residual Solvents/Impurities
    • USP (all classes of residual solvents in current chapter)
    • Customized method development/validation
    • Extractables/Leachables
      • Forced extraction studies
      • Controlled extraction studies
  • Validation of disposables for use in Biomanufacturing
  • Customized method development/validation
    Specific example of methods include:
    • Phthalate esters by GC/MS in tablets
    • Benzo(a)pyrene by HPLC and GC/MS in final finished product
    • Nitrosamines in metered dose inhaler O-ring components
    • Trace metals by Inductively Coupled Plasma in drug products
  • Process Impurities/Related Compounds
    • Customized method development/validation
    • HPLC product and API specific methodology
    • Qualitative/Quantitative analysis
    • Tracking/trending of resulting stability studies
  • Degradation Products
    • Customized method development/validation
    • Forced degradation studies
    • HPLC product and API specific methodology
    • Qualitative/Quantitative analysis
    • Tracking/trending of resulting stability studies
  • Trace Metals
    • Qualitative/Quantitative limits testing (using ICP and ICP/MS approaches)
  • Elemental Analysis
    • Qualitative/Quantitative limits testing (using AA and CHN approaches)

Instrumentation

  • Mass Spectrometers (Agilent, Perkin Elmer, Thermo Scientific, Waters)
  • Chromatography Equipment (Agilent, Dionex)
  • Detectors
  • Spectrophotometers (Perkin Elmer)

Click here to view a full list of our instrumentation.

Contact Us

Request more information to start working with us today. Or call one of our Business Development Specialists at 717-656-2300.